Digital Health Solutions

Digital Health Solutions (DHS) is a trusted partner to MedTech innovators, providing end-to-end product development and regulatory expertise that helps bring medical technologies to market faster. We have partnered with companies of all sizes to cost-effectively implement quality systems tailored to their needs, including cloud-based eQMS platforms like Qualio. By combining deep technical expertise with regulatory insight, DHS ensures medical innovations are delivered on time, on budget, and audit-ready, enabling startups and Tier 1 manufacturers alike to accelerate time to market while maintaining the highest standards of safety, compliance, and quality. With a global team of engineers, regulatory specialists, and manufacturing experts, DHS delivers cost-effective solutions backed by offices in Andover, MA, USA and Mumbai, India for around-the-clock collaboration.

Core Capabilities

• End-to-End Product Development for Medical Devices
• Firmware & Software Engineering across embedded systems, mobile, and cloud
• Cybersecurity aligned with FDA, CE, and global regulatory standards
• Systems Engineering including risk management, requirements, and V&V
• Quality & Regulatory Services helping customers craft regulatory strategies and implement eQMS systems such as Qualio for compliance and scalability
• ISO 13485 Contract Manufacturing ensuring quality and production readiness

Expertise Across Devices & Platforms

DHS works across the full spectrum of medical technologies, from Class I, II, and III medical devices to connected embedded devices, compliant IoT and cloud platforms, medical wearables, point-of-care diagnostics, SaMD, and mobile health applications. Our breadth of expertise allows us to support innovators in translating cutting-edge ideas into safe, effective, and compliant products.